Comparison of Effectiveness of Dry needling and Electroacupuncture of upper trapezius muscle on pain, Ultrasonography changes and Functional disability of Upper limb in patients with Myofascial pain syndrome
The effect of Dry needling and Electroacupuncture on pain and functional disability and ultrasonography changes in patients with myofacial pain syndrome
Design
The study is a double-blind randomized clinical trial. 42 patients with myofascial pain syndrome are randomly divided into two groups. Stratified Permuted Block Randomization method is used for randomization.
Settings and conduct
This study is performed at the Semnan neuromuscular Rehabilitation Research Center. Patients are invited to participate in the study. In the first intervention group, dry needling of the upper trapezius muscle and in the second intervention group, electroacupuncture of the upper trapezius muscle will be performed. Measurement of muscle thickness and assessment of pain and functional disability will be done once before the intervention and once after the intervention. The researcher will be blind to the intervention by employing the research assistant. The outcome assessor will be different from the researcher and is not aware of the interlopers. In each group, they are not aware of the intervention of the other group
Participants/Inclusion and exclusion criteria
Inclusion criteria: The presence of a tight band and sensitive points to pain;
Having a referral pain pattern; People with a body mass index between 20 and 29;At least 3 months have passed since the pain started
Exclusion criteria: diabetes; pregnancy; Fibromyalgia disease; Needle phobia; Hypersensitivity to needle; History of neck and shoulder surgery; Rheumatoid arthritis and degenerative diseases; myopathy; neuropathy; myelopathy; torticollis; radiculopathy
Intervention groups
In the first intervention group, dry needling of the upper trapezius muscle will be performed. In the second intervention group, electroacupuncture of the upper trapezius muscle will be performed.
Main outcome variables
Muscle thickness; pain; functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221008056115N1
Registration date:2022-10-26, 1401/08/04
Registration timing:prospective
Last update:2022-10-26, 1401/08/04
Update count:0
Registration date
2022-10-26, 1401/08/04
Registrant information
Name
Seyed Zia Safavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
jajarmi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Dry needling and Electroacupuncture of upper trapezius muscle on pain, Ultrasonography changes and Functional disability of Upper limb in patients with Myofascial pain syndrome
Public title
The Effectiveness of Dry needling and Electroacupuncture on Myofascial pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of a tight band and sensitive points to pain
Having a referral pain pattern
People with a body mass index between 20 and 29
At least 3 months have passed since the pain started and no specific reason has been mentioned about the cause of the pain
Exclusion criteria:
diabetes
pregnancy
Fibromyalgia disease
Needle phobia
Hypersensitivity to needle
History of neck and shoulder surgery
Rheumatoid arthritis and degenerative diseases, myopathy, neuropathy, myelopathy, torticollis, radiculopathy
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are assigned (to two groups) randomly and using the method of random permutation blocks with 6 blocks of 6, assigned to the two groups. In this method, A will represent the first intervention group and B will represent the second intervention group. In this way, the order of A and B interventions in the form of blocks from 1 to 6 is determined by the methodological consultant of the project, and is provided to the executive supervisor of the project, and the researcher obtains an assignment from the executive supervisor to assign each qualified person. The supervisor first selects the block using a random number generator (or dice roll) and then the eligible individuals are assigned to one of the two groups A or B. And the sequence of each item will be crossed out. It should be noted that if a block is selected based on random numbers that have already filled all 6 sequences, another random number will be selected again for that person.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher will be blind to the intervention by employing the research assistant and not being in the intervention room. The outcome assessor will be different from the researcher and will only receive the study data with a code from the researcher and is not aware of the interlopers. In each group, they are not aware of the intervention of the other group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.SEMUMS.REC.1401.162
Health conditions studied
1
Description of health condition studied
Myofacial pain syndrome
ICD-10 code
M79.1
ICD-10 code description
Myalgia
Primary outcomes
1
Description
The thickness of the upper trapezius muscle
Timepoint
Before the intervention and after the intervention
Method of measurement
Ultrasonography device
2
Description
Functional disability
Timepoint
Before the intervention and after the intervention
Method of measurement
Disability of the Arm, Shoulder and Hand questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Dry needling of upper trapezius muscle will be performed 2 sessions per week for 2 consecutive weeks. To perform the intervention, the patient is placed in pron position, and the therapist is placed above the patient's head and cleans the skin with alcohol. The needles are inserted into the muscle at the midpoint of the line extending from the seventh cervical vertebra to the acromion process, on the trigger points, and will remain in the muscle for 15 minutes.
Category
Treatment - Other
2
Description
Second Intervention group: Electroacupuncture of upper trapezius muscle will be performed 2 sessions per week for 2 consecutive weeks. To perform the intervention, the patient is placed in pron position, and the therapist is placed above the patient's head and cleans the skin with alcohol. The needles are inserted into the muscle at the middle point of the line that extends from the seventh cervical vertebra to the acarion process, on the trigger points, and electroacupuncture with a frequency of 100 Hz is continuously applied for 15 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Mohama Reza Jajarmi
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
nmrrc@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
مجید میرمحمد خانی
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyed Zia Safavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
ziasafavi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyed Zia Safavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
ziasafavi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyed Zia Safavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
ziasafavi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD